510(k) Report

Devices descending from K030883

524 later devices reach Omnilux Blue through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+9K183450EmBody SystemInmode MD, Ltd.20198—
+9K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+10K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+10K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+10K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+11K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+11K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+11K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K230167BACK 4Swims America Corp20230—
+11K230037BACK 3Swims America Corp20230—
+11K213889PicoStarAsclepion Laser Technologies GmbH20220—
+11K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+12K202503ChromeQuanta System Spa202012—
+13K253765Vanish ProDdc Technologies, Inc.20260—
+13K250281Deka LotusEl.En S.P.A.20250—
+13K241527Pastelle ProWontech Co., Ltd.20253—
+13K233473Deka LotusEl.En S.P.A.20241—
+13K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+13K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+13K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+14K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—